ANSI/AAMI/ISO 13408-1:2008 (R2011)/A1:2013

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Aseptic processing of health care products - Part 1: General requirements (includes Amendment 1).

Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products.

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Association for the Advancement of Medical Instrumentation [aami]

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Aseptic processing of health care products - Part 1: General requirements (includes Amendment 1).

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Historical

ANSI/AAMI/ISO 13408-1:2008 (R2011)/A1:2013

Aseptic processing of health care products - Part 1: General requirements (includes Amendment 1).

Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?

Useful Links

CUSTOMER SERVICE

Our Contacts